A Randomized, Parallel-group Comparison Exploratory Study of Kamikihito for Anxiety in Frail Patients

JRCT ID: jRCTs041180056

Registered date:27/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: anxiety in frail with depression symptom
• Date of first enrollment: 04/07/2018
• Target sample size: 50
• Study type: Interventional
• Intervention(s): TSUMURA Kamikihito Extract Granules, 7.5g per day, 24 weeks

Outcome(s)

• Primary Outcome: Anxiety, Depression: HADS (Hospital Anxiety and Depression Scale) at 24 weeks

Secondary Outcome

24 weeks
1. Fatigue: Chalder's fatigue scale
2. Appetite: SNAQ-JE, Simplified Nutritional Appetite Questionnaire for the Japanese elderly
3. The Kihon Checklist
4. Activity: Actigraph
5. Body composition: body weight, lean body mass/fat mass
6. Physical performance: SPPB, Short Physical Performance Battery; handgrip strength
7. Cognitive function: MMSE, MINI-Mental State Examination; NCGG-FAT, National Center for Geriatrics and Gerontology-Functional Assessment Tool

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Frail or pre-frail patient: the Kihon Checklist > 3 points
2. Patient who has possessed of the Kihon Checklist No. 21 to 25 for depression > 1 point at baseline
3. Patient who has possessed of HADS-A score > 3 points at baseline

Exclude criteria

1. Patient who has had surgical resection of gastrointestinal tract or under the treatment for gastrointestinal disturbance
2. Dementia, major depression or bipolar disorder within the previous year, and alcoholism, drug addiction, within the previous 2 years
3. Patients who has life-threatening diseases such as malignant tumor

Related Information

• Primary Sponsor: Arai Hidenori
• Secondary Sponsor: Tsumura & CO.
• Secondary ID(s): UMIN000036539